Pharmacy Operations and Drug Scheduling Act - BYLAWS Table of Contents

1. Definitions

PART I All Pharmacies 2. Application of Part

3. 4. 5. 6. 7. 8. 9. Responsibilities of Pharmacy Managers, Owners and Directors Sale and Disposal of Drugs Drug Procurement/Inventory Management Interchangeable Drugs Returned Drugs Records Pharmacy Licences

PART II Community Pharmacies 10. Community Pharmacy Manager Quality Management

11. 12. 13. Community Pharmacy Premises Operation Without a Full Pharmacist Outsource Prescription Processing

PART III Hospital Pharmacies 14. Hospital Pharmacy Manager Quality Management
15. After Hours Service

PART IV Telepharmacy 16. Telepharmacy Services PART V Pharmacy Education Sites 17. Pharmacy Education Site Manager PART VI PharmaNet 18. Application of Part
19. 20. 21. 22. Definitions Operation of PharmaNet Data Collection, Transmission of and Access to PharmaNet Data Confidentiality

SCHEDULES
Schedule A Fee Schedule

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FORMS
1. 2. 3. 4. 5. 6. New Pharmacy Application Telepharmacy Services Application Hospital Pharmacy Satellite Application Community Pharmacy Licence Renewal Notice Hospital Pharmacy Licence Renewal Notice Education Site License Renewal Notice

Definitions In these bylaws: 1.

Act means the Pharmacy Operations and Drug Scheduling Act; central pharmacy site means a pharmacy authorized under Part IV to provide telepharmacy services; community pharmacy means a pharmacy licensed to sell or dispense drugs to the public; Community Pharmacy Standards of Practice means the standards, limits and conditions for practice established under section 19 (1) (k) of the Health Professions Act respecting community pharmacies; controlled drug substance means a drug which includes a substance listed in Schedule I, II, III, IV or V of the Controlled Drugs and Substances Act (Canada); controlled prescription program means a program approved by the board, to prevent prescription forgery and reduce inappropriate prescribing of drugs; dispensary means the area of a community pharmacy that contains Schedule I and II drugs; health authority means (a) a regional health board designated under the Health Authorities Act, or (b) the Provincial Health Services Authority; hospital has the same meaning as in section 1 of the Hospital Act; hospital pharmacy means a pharmacy licensed to operate in or for a hospital; hospital pharmacy satellite means a physically separate area on or outside the hospital premises used for the provision of pharmacy services which is dependent upon support and administrative services from the hospital pharmacy; Hospital Pharmacy Standards of Practice means the standards, limits and conditions for practice established under section 19 (1) (k) of the Health Professions Act respecting hospital pharmacies; medication has the same meaning as drug;
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outsource prescription processing means to request another pharmacy to prepare or process a prescription drug order; patients representative has the same meaning as in section 64 of the bylaws of the college under the Health Professions Act; pharmacy assistant has the same meaning as support person; pharmacy education site means a pharmacy (a) that has Schedule I, II and III drugs, but no controlled drug substances, (b) that is licensed solely for the purpose of pharmacy education, and (c) from which pharmacy services are not provided to any person; pharmacy technician has the same meaning as in section 1 of the bylaws of the college under the Health Professions Act; pharmacy services has the same meaning as in section 1 of the bylaws of the college under the Health Professions Act; prescription drug means a drug referred to in a prescription; professional products area means the area of a community pharmacy that contains Schedule III drugs; professional service area means the area of a community pharmacy that contains Schedule II drugs; Residential Care Facilities and Homes Standards of Practice means the standards, limits and conditions for practice established under section 19 (1) (k) of the Health Professions Act respecting residential care facilities and homes; telepharmacy means the process by which a central pharmacy site operates one or more telepharmacy remote sites, all of which are connected to the central pharmacy site via computer, video and audio link; telepharmacy services means prescription processing or other pharmacy services, provided by or through telepharmacy; telepharmacy remote site means a pharmacy providing pharmacy services to the public, or in or for a hospital, (a) without a full pharmacist present, (b) in a rural or remote community, and (c) under the supervision and direction of a full at a central pharmacy site.

PART I - All Pharmacies Application of Part 2. This Part applies to all pharmacies except pharmacy education sites. Responsibilities of Pharmacy Managers, Owners and Directors 3. (1) A full pharmacist may not act as manager of more than one pharmacy location, unless the pharmacy of which the full pharmacist is manager
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includes (a) (b) (c) (d) (2) a telepharmacy remote site, a hospital pharmacy, a hospital pharmacy satellite, or a pharmacy education site.

A manager must do all of the following: (a) (b) (c) (d) (e) actively participate in the day-to-day management of the pharmacy; confirm that the staff members who represent themselves as registrants are registrants; notify the registrar in writing of the appointments and resignations of registrants as they occur; cooperate with inspectors acting under section 17 of the Act or sections 28 or 29 of the Health Professions Act; ensure that registrant and pharmacy assistant staff levels are commensurate with the workload volume and patient care requirements at all times; ensure that new information directed to the pharmacy pertaining to drugs, devices and drug diversion is immediately accessible to registrants and pharmacy assistants; establish policies and procedures to specify the duties to be performed by registrants and pharmacy assistants; establish procedures for (i) inventory management, (ii) product selection, and (iii) proper destruction of unusable drugs and devices; ensure that all records related to the purchase and receipt of controlled drug substances are signed by a full pharmacist; ensure appropriate security and storage of all Schedule I, II, and III drugs and controlled drug substances for all aspects of pharmacy practice including operation of the pharmacy without a registrant present; ensure there is a written drug recall procedure in place for pharmacy inventory; ensure that all steps in the drug recall procedure are documented, if the procedure is initiated;

(f)

(g) (h)

(i) (j)

(k) (l)

(m) ensure that each individual working in the pharmacy wears a badge that clearly identifies the individuals registrant class or other status; (n) ensure that confidentiality is maintained with respect to all pharmacy and
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patient records in accordance with all applicable legislation; (o) make reasonable security arrangements in respect of unauthorized access, collection, use, disclosure or disposal of personal information kept on the pharmacy premises; notify the registrar as soon as possible in the event that he or she will be absent from the pharmacy for more than eight weeks; notify the registrar in writing within 48 hours of ceasing to be the pharmacys manager; ensure the correct and consistent use of the community pharmacy operating name as it appears on the community pharmacy licence for all pharmacy identification on or in labels, directory listings, signage, packaging, advertising and stationery; ensure that appropriate security is in place for the premises generally; in the event of a pharmacy closure or relocation, (i) notify the registrar in writing at least thirty days before the effective date of a proposed closure or relocation, unless the registrar determines there are extenuating circumstances, (ii) (iii) (iv) provide for the safe transfer and appropriate storage of all Schedule I, II, and III drugs and controlled drug substances, advise the registrar in writing of the disposition of all drugs and prescription records at the time of a closure, provide the registrar with a copy of the return invoice and any other documentation sent to Health Canada in respect of the destruction of all controlled drug substances, arrange for the safe transfer and continuing availability of the prescription records at another pharmacy, or an off-site storage facility that is bonded and secure, and remove all signs and advertisements from the closed pharmacy premises;

(p) (q) (r)

(s) (t)

(v)

(vi) (u) (v)

ensure sample medications are dispensed in accordance with the requirements in the Drug Schedules Regulation; advise the registrar if the pharmacy is providing pharmacy services over the internet, and provide to the registrar the internet address of every website operated or used by the pharmacy;

(w) ensure the pharmacy contains the reference material and equipment approved by the board from time to time; (x) require all registrants, owners, managers, directors, pharmaceutical representatives, pharmacy assistants and computer software programmers or technicians who will access the in-pharmacy computer system to sign an undertaking in a form approved by the registrar to
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maintain the confidentiality of patient record information; (y) (z) retain the undertakings referred to in paragraph (x) in the pharmacy for 3 years after employment or any contract for services has ended; be informed of the emergency preparedness plan in the area of the pharmacy that he or she manages and be aware of his or her responsibilities in conjunction with that plan.

(3) (4) (5) (6) (7)

Subsection (2)(r) does not apply to a hospital pharmacy, hospital pharmacy satellite or a pharmacy education site. Owners and directors must comply with subsection (2) (d), (e), (j), (n), (o), (r), (s), (t), (v), (w), and (x). An owner or director must appoint a manager whenever necessary, and notify the registrar in writing of the appointment and any resignation of a manager. An owner must ensure that the requirements to obtain a pharmacy licence under the Act are met at all times. For the purpose of subsection (2)(t), a pharmacy closure includes a suspension of the pharmacy licence for a period greater than 30 days, unless otherwise directed by the registrar.

Sale and Disposal of Drugs 4. (1) Schedule I, II, and III drugs and controlled drug substances must only be sold or dispensed from a pharmacy.
(2) A registrant must not sell or dispense a quantity of drug that will not be used completely prior to the manufacturers expiry date, if used according to the directions on the label. If the manufacturers expiry date states the month and year but not the date, the expiry date is the last day of the month indicated. Every registrant practising in a pharmacy is responsible for the protection from loss, theft or unlawful sale or dispensing of all Schedule I, II, and III drugs and controlled drug substances in or from the pharmacy. A registrant must not sell, dispense, dispose of or transfer a Schedule I drug except (a) (b) (c) (d) (6) on the prescription or order of a practitioner, for an inventory transfer to a pharmacy by order of a registrant in accordance with the policy approved by the board, by return to the manufacturer or wholesaler of the drug, or by destruction, in accordance with the policy approved by the board.

(3) (4)

(5)

Drugs included in the controlled prescription program must not be sold or dispensed unless
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(a)

the registrant has received the prescription on the prescription form approved by both the board and the College of Physicians and Surgeons of British Columbia, and the prescription form is signed by the patient or the patients representative upon receipt of the dispensed drug.

(b) (7)

A new prescription from a practitioner is required each time a drug is dispensed, except for (a) (b) (c) (d) a part-fill, a prescription authorizing repeats, a full pharmacist-initiated renewal or adaptation, or an emergency supply for continuity of care.

(8)

Subsection (6) does not apply to prescriptions written for (a) (b) residents of a facility or home subject to the requirements of the Residential Care Facilities and Homes Standards of Practice, or patients admitted to a hospital.

Drug Procurement/Inventory Management 5. (1) A full pharmacist may authorize the purchase of Schedule I, II, or III drugs or controlled drug substances only from
(a) (b) (2) a wholesaler or manufacturer licensed to operate in Canada, or another pharmacy in accordance with the policy approved by the board.

A registrant must record a transfer of drugs that occurs for any reason other than for the purpose of dispensing in accordance with a practitioners prescription. All drug shipments must be delivered unopened to the pharmacy or a secure storage area. Non-usable and expired drugs must be stored in a separate area of the pharmacy or a secure storage area until final disposal. A full pharmacist must not purchase Schedule I, II and III drugs and controlled drug substances unless they are for sale or dispensing in or from a pharmacy.

(3) (4) (5)

Interchangeable Drugs When acting under section 25.91 of the Health Professions Act, a full 6. pharmacist must determine interchangeability of drugs by reference to Health Canadas Declaration of Equivalence, indicated by the identification of a Canadian Reference Product in a Notice of Compliance for a generic drug.

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Returned Drugs

7.

No registrant may accept for return to stock or reuse any drug previously dispensed except in accordance with section 11(3) of the Residential Care Facilities and Homes Standards of Practice or section 5(2) of the Hospital Pharmacy Standards of Practice.

Records 8. (1)

All prescriptions, patient records, invoices and documentation in respect of the purchase, receipt or transfer of Schedule I, II and III drugs and controlled drug substances must be retained for a period of not less than three years from the date (a) (b) a drug referred to in a prescription was last dispensed, or an invoice was received for pharmacy stock.

(2)

Registrants, pharmacy assistants, managers, directors, and owners must not, for commercial purposes, disclose or permit the disclosure of information or an abstract of information obtained from a prescription or patient record which would permit the identity of the patient or practitioner to be determined. Despite subsection (1), a registrant must not destroy prescriptions, patient records, invoices or documentation until the completion of any audit or investigation currently underway for which the registrant has received notice.

(3)

Pharmacy Licences 9. (1) The registrar may issue a licence for any of the following:
(a) (b) (c) (2) a community pharmacy; a hospital pharmacy; a pharmacy education site.

An applicant for a pharmacy licence must submit the following to the registrar: (a) (b) a completed application in Form 1; a diagram to scale of inch equals 1 foot scale including the measurements, preparation, dispensing, consulting, storage, professional service area, professional products area, entrances and packaging areas of the pharmacy; the applicable fee set out in Schedule A; for a community pharmacy, proof in a form satisfactory to the registrar that the municipality in which the pharmacy is located has issued a business licence for the pharmacy to the pharmacys owner or manager.

(c) (d)

(3)

The registrar may renew a pharmacy licence upon receipt of the following: (a) a completed notice in Form 4, 5 or 6, as applicable, signed by the
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manager; (b) (4) the applicable fee set out in Schedule A.

A pharmacys manager must submit to the registrar, in writing, any proposed pharmacy design changes or structural renovations together with a new pharmacy diagram for approval before the commencement of construction or other related activities. If a pharmacy will be closed temporarily for up to 14 consecutive days, the pharmacys manager must (a) (b) (c) obtain the approval of the registrar, notify patients and the public of the closure at least 30 days prior to the start of the closure, and make arrangements for emergency access to the pharmacys hard copy patient records.

(5)

(6)

A pharmacy located in a hospital which dispenses drugs to staff, out-patients or the public and which is not owned or operated by a health authority, must be licenced as a community pharmacy. Subsections (4) to (6) do not apply to a pharmacy education site.

(7)

PART II Community Pharmacies Community Pharmacy Manager Quality Management 10. A community pharmacys manager must develop, document and implement an ongoing quality management program that
(a) maintains and enforces policies and procedures to comply with all legislation applicable to the operation of a community pharmacy, (b) monitors staff performance, equipment, facilities and adherence to the Community Pharmacy Standards of Practice, and (c) includes a process for reporting, documenting and following up on known, alleged and suspected errors, incidents and discrepancies.

Community Pharmacy Premises 11. (1) In locations where a community pharmacy does not comprise 100 per cent of the total area of the premises, the community pharmacys manager must ensure that
(a) the professional products area extends not more than 25 feet from the perimeter of the dispensary and is visually distinctive from the remaining areas of the premises by signage, and a sign reading Medication Information is clearly displayed to identify a consultation area or counter at which a member of the public can obtain
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(b)

a full pharmacists advice. (2) The dispensary area of a community pharmacy must (a) (b) (c) (d) (e) (f) (3) be at least 160 square feet, be inaccessible to the public by means of gates or doors across all entrances, include a dispensing counter with at least 30 square feet of clear working space, in addition to service counters, contain adequate shelf and storage space, contain a double stainless steel sink with hot and cold running water, and contain an adequate stock of drugs to provide full dispensing services.

In all new and renovated community pharmacies, an appropriate area must be provided for patient consultation that (a) (b) ensures privacy and is conducive to confidential communication, and includes, but is not limited to, one of the following: (i) (ii) a private consultation room; a semiprivate area with suitable barriers.

(4)

All new and renovated community pharmacies must have a separate and distinct area consisting of at least 40 square feet reserved as secure storage space.

Operation Without a Full Pharmacist 12. (1) Except as provided in subsection (2), a community pharmacy must not be open to the public unless a full pharmacist is present.
(2) A community pharmacy that does not have a telepharmacy remote site licence may operate without a full pharmacist present if all the following requirements are met: (a) (b) the registrar is notified of the hours during which a full pharmacist is not present; a security system prevents the public, pharmacy assistants and other non-pharmacy staff from accessing the dispensary, the professional service area and the professional products area; a pharmacy technician is present and ensures that the pharmacy is not open to the public; Schedule I, II, and III drugs and controlled drug substances in a secure storage area are inaccessible to pharmacy assistants, other nonpharmacy staff and the public; dispensed prescriptions waiting for pickup may be kept outside the
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(c) (d)

(e)

dispensary if they are inaccessible, secure and invisible to the public and the requirements of section 12 of the Community Pharmacy Standards of Practice have been met; (f) (3) the hours when a full pharmacist is on duty are posted.

If the requirements of subsection (2) are met, the following activities may be performed at a community pharmacy by anyone who is not a registrant: (a) requests for prescriptions, orders for Schedule II and III drugs and telephone requests from patients to order a certain prescription may be placed in the dispensary area by dropping them through a slot in the barrier; orders from drug wholesalers, containing Schedule I, II and III drugs, may be received but must be kept secure and remain unopened.

(b)

Outsource Prescription Processing 13. (1) A community pharmacy may outsource prescription processing if
(a) (b) (c) (2) all locations involved in the outsourcing are community pharmacies, all prescriptions dispensed are labeled and include an identifiable code that provides a complete audit trail for the dispensed drug, and a notice is posted informing patients that the preparation of their prescription may be outsourced to another pharmacy.

The manager of an outsourcing community pharmacy must ensure that all applicable standards of practice are met in processing prescriptions at all locations involved in the outsourcing. In this section, community pharmacy includes a hospital pharmacy.

(3)

PART III Hospital Pharmacies Hospital Pharmacy Manager Quality Management 14. (1) A hospital pharmacys manager must develop, document and implement an ongoing quality management program that
(a) (b) (c) (d) (e) (f) maintains and enforces policies and procedures to comply with all legislation applicable to the operation of a hospital pharmacy, monitors staff performance, equipment, facilities and adherence to the Hospital Pharmacy Standards of Practice, includes a process for reporting, documenting and following up on known, alleged and suspected errors, incidents and discrepancies, documents periodic audits of the drug distribution process, includes a process to review patient-oriented recommendations, includes a process that reviews a full pharmacists documentation notes
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in the hospitals medical records, (g) (h) includes a process to evaluate drug use, and regularly updates policies and procedures for drug use control and patient-oriented pharmacy services in collaboration with the medical and nursing staff and appropriate committees.

(2)

If sample drugs are used within a hospital, the hospital pharmacys manager must ensure that the pharmacy oversees the procurement, storage and distribution of all sample drugs.

After Hours Service 15. (1) If continuous pharmacy services are not provided in a hospital, the hospital pharmacys manager must ensure that urgently needed drugs and patientoriented pharmacy services are available at all times by
(a) providing a cabinet which must (i) be a locked cabinet or other secure enclosure located outside of the hospital pharmacy, to which only authorized persons may obtain access, be stocked with a minimum supply of drugs most commonly required for urgent use, not contain controlled drug substances unless they are provided by an automated dispensing system,

(ii) (iii)

(iv) contain drugs that are packaged to ensure integrity of the drug and labeled with the drug name, strength, quantity, expiry date and lot number, and (v) (b) (2) include a log in which drug withdrawals are documented, and

arranging for a full pharmacist to be available for consultation on an oncall basis.

When a hospital pharmacy or hospital pharmacy satellite is closed, the premises must be equipped with a security system that will detect unauthorized entry.

PART IV Telepharmacy Telepharmacy Services 16. (1) The registrar may authorize a community pharmacy or hospital pharmacy to provide telepharmacy services, upon receipt of a completed application in Form 2 and if satisfied that the requirements of this section will be met.
(2) (3) Telepharmacy services may only be provided in or through pharmacies authorized under this Part to provide telepharmacy services. A telepharmacy remote site must be under the direct supervision of a full
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pharmacist at the central pharmacy site. (4) (5) A telepharmacy remote site must be under the responsibility of the manager of the central pharmacy site. The Community Pharmacy Standards of Practice apply to a telepharmacy remote site, unless it is located in, or providing pharmacy services for, a hospital in which case the Hospital Pharmacy Standards of Practice apply. Full pharmacists at a central pharmacy site must comply with section 12 of the Community Pharmacy Standards of Practice by using video and audio links. A sign must be posted at the dispensary counter of a telepharmacy remote site advising patients and staff when the site is operating in telepharmacy mode. A telepharmacy remote site must not remain open and prescriptions must not be dispensed if (a) (b) (c) (9) an interruption in data, video or audio link occurs, a pharmacy technician is not on duty at the telepharmacy remote site, or a full pharmacist is not on duty at the central pharmacy site.

(6) (7)

(8)

Prescriptions dispensed at a telepharmacy remote site must be distinguishable from a prescription dispensed at the central pharmacy site and include a unique label and a unique identifier for the prescription.

(10) The manager of a central pharmacy site must (a) (b) (c) inspect and audit each affiliated telepharmacy remote site at least 3 times each year, make a written record of all inspections and audits, and provide a copy of a record described in paragraph (b) to the college on request.

(11) There must be a policy and procedure manual which describes the specific telepharmacy operations that are in place to ensure the safe and effective distribution of pharmacy products and delivery of pharmaceutical care.

PART V Pharmacy Education Sites Pharmacy Education Site Manager 17. (1) A pharmacy education sites manager must ensure that only registrants and instructors are present in the pharmacy education site.
(2) A pharmacy education sites manager must comply with section 3(2)(a), (d), (h), (p), (s) and (t)(ii) and (iii).

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PART VI PharmaNet Application of Part 18. This Part applies to every pharmacy that connects to PharmaNet. Definitions 19. In this Part:
database means those portions of the provincial computerized pharmacy network and database referred to in section 13 of the Act; in-pharmacy computer system means the computer hardware and software utilized to support pharmacy services in a pharmacy; patient keyword means an optional confidential pass code selected by the patient which limits access to the patients PharmaNet record until the pass code is provided to the registrant; PharmaNet patient record means the patient record described in section 11(2) of the Community Pharmacy Standards of Practice and in the PharmaNet Professional and Software Compliance Standards as the patient profile; PharmaNet Professional and Software Compliance Standards means the document provided by the Ministry of Health Services specifying the requirements of an in-pharmacy computer system to connect to PharmaNet; terminal means any electronic device connected to a computer system, which allows input or display of information contained within that computer system.

Operation of PharmaNet 20. A pharmacy must connect to PharmaNet and be equipped with the following:
(a) an in-pharmacy computer system which meets the requirements set out in the current PharmaNet Professional and Software Compliance Standards; a terminal that is capable of accessing and displaying patient records, located in an area of the pharmacy which (i) (ii) (iii) is only accessible to registrants and pharmacy assistants, is under the direct supervision of a registrant, and does not allow information to be visible to the public, unless intended to display information to a specific patient;

(b)

(c) the computer software upgrades necessary to comply with changes to the PharmaNet Professional and Software Compliance Standards.

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Data Collection, Transmission of and Access to PharmaNet Data

21. (1) A registrant must enter the prescription information and transmit it to PharmaNet at the time of dispensing and keep the PharmaNet patient record current. A registrant may collect and transmit patient record information to PharmaNet or access a patients PharmaNet record only (a) (b) (c) (3) to dispense a drug, to provide patient consultation, or to evaluate a patients drug usage.

(2)

A registrant may collect and transmit patient record information to PharmaNet or access a patients PharmaNet record only for the purposes of claims adjudication and payment by an insurer. A registrant must revise information in the PharmaNet database pertaining to corrected billings for prescriptions billed to the patient or a payment agency other than PharmaCare and record the reason for the revision within 90 days of the original entry on PharmaNet. A registrant must reverse information in the PharmaNet database, for any drug that is not released to the patient or the patients representative, and record the reason for the reversal no later than 30 days from the date of the original entry of the prescription information in PharmaNet. If a registrant is unable to comply with the deadlines in subsections (4) or (5), he or she must provide the information required to make the correction to the college as soon as possible thereafter. At the request of the patient, a registrant must establish, delete or change the patient keyword. Where a patient or patients representative requests an alteration to be made to the PharmaNet information, the registrant must (a) (b) correct the information, or if the registrant refuses to alter the information, he or she must inform the person requesting the change of his or her right to request correction under the Personal Information Protection Act.

(4)

(5)

(6)

(7) (8)

Confidentiality 22. A registrant must take reasonable steps to confirm the identity of a patient, patients representative, registrant or practitioner before providing any pharmacy service, including but not limited to
(a) establishing a patient record,

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(b) (c) (d) (e) (f) (g) (h)

updating a patients clinical information, providing a printout of an in-pharmacy or requesting a PharmaNet patient record, establishing, deleting, or changing a patient keyword, viewing a patient record, answering questions regarding the existence and content of a patient record, correcting information, and disclosing relevant patient record information to another registrant for the purpose of dispensing a drug or device, and/or for the purpose of monitoring drug use.

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